QC Analyst II - Analytical (Evening Shift)

Tbwa Chiat/Day Inc • Lexington, MA, United States • $200k - $250k / year • 1w ago

QC Analyst II - Analytical (Evening Shift)

Lexington, MA

The field of gene therapy is growing rapidly, and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company, and you can be part of that team.

JOB SUMMARY

The QC Analyst II will be responsible for routine and non-routine QC testing according to Standard Operating Procedures (SOPs). This position is based at Genezen’s new state-of-the-art facility in Lexington, MA. This role supports the evening and occasional weekend operations within the Quality Control group via execution of analytical testing and Quality Systems. This includes but is not limited to in-process testing, lot release testing, and stability testing. Execution of quality systems entails deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls. These activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.

ESSENTIAL JOB FUNCTIONS

Perform routine/non-routine testing and review of in-process, DS and DP release and stability samples in accordance with Standard Operating Procedures (q-PCR, HPLC, Osmolality, Western Blot, etc.)
Perform peer review with minimal errors.
Able to work effectively in internal/cross-functional teams as an active member. Train and execute on assays cross-functionally to support deadlines for release.
Participate in equipment validation, method transfer/validation, and special protocol execution.
Responsible for protocol and report generation/revision/review, as required.
Strong understanding of regulations, able to apply to any situation, and identify deficiencies with some guidance.

SPECIAL JOB REQUIREMENTS

Adaptability required as work schedule may change based on business needs.
Criminal background check required.
Other duties as assigned.

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

BA or BS in Chemistry/Biochemistry or other related science.

ON-THE-JOB EXPERIENCE

Minimum 0-5+ years of laboratory-based experience within QC testing capacity, preferably in a cGMP environment.

High proficiency in q-PCR and HPLC methods and analysis.

Follow procedures trained on and complete documentation applying cGMP/GDP/ALCOA+.

Understanding of industry testing requirements/standards.

SKILLS/ABILITIES

Computer literacy (MS Word, Excel, and LIMS).

Good/effective communication and organizational skills with the ability to work well with others and independently.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Regularly sit for long periods of time.
Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms.
Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
Frequently lift and/or move up to 10 pounds; rarely lift and/or move up to 25 pounds.
Frequently utilize close vision and the ability to adjust focus.
Frequently required to communicate by talking, hearing, using telephone and e-mail.

GENEZEN'S CURES VALUE-BASED COMPETENCIES

Committed to Science: We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

Urgency in action for the patients: We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

Resilience & Grit in operations: We are committed to overcoming challenges, learning from failures, and persistently striving for success.

Execute with Excellence & Integrity: We are dedicated to delivering quality results and upholding ethical principles.

Solutions driven for our partners: We are committed to being a proactive, collaborative, creative, and open-minded partner.

GENEZEN'S BENEFITS

Paid vacation days, amount based on tenure.
401(k) plan with company match up to 6% of salary, vested immediately.
Choice of several healthcare plans.
FSA and HSA programs.
Employer-paid basic term life/personal accident insurance.
Voluntary disability, universal life/personal accident insurance.

ADDITIONAL DETAILS

Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
This position requires a criminal background check.
Genezen is an Equal Opportunity Employer.
Genezen participates in E-Verify.
Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

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